GEN News Highlights

Shire Expands Into Neonatology with Premacure Acquisition

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In a deal that builds its rare-disease drug pipeline while expanding its therapeutic offerings into neonatology, Shire said today it is buying Swedish-owned Premacure, the developer of a protein replacement therapy now in Phase II development for prevention of retinopathy of prematurity (ROP).

The price was not disclosed, although Shire said it will acquire Premacure for an up-front payment plus contingent payments tied to achieving development and commercial milestones.

Shire said its Human Genetic Therapies (Shire HGT) unit will continue an ongoing Phase II safety and efficacy multi-center clinical trial for the protein replacement therapy, being marketed under the brand name Premiplex®.

The Phase II trial’s primary goal is to restore the insulin-like growth factor 1 (IGF-1) levels in premature infants to those found during normal in utero development. ROP, one of the most common causes of visual loss in childhood, primarily affects premature infants weighing less than two pounds who are born before 31 weeks of gestation.

Established in 2006, privately-held Premacure has pursued clinical development of Premiplex. The protein replacement therapy’s formulation combines recombinant human IGF-1 and a recombinant version of its naturally occurring binding protein, insulin-like growth factor-1 binding protein-3 (IFGBP3).

During a Phase I clinical trial of the therapy, administration of the investigational protein to preterm infants was generally well tolerated while the presence of IGF-1 was increased to within physiological levels.

“This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and impact of complications arising from ROP,” Flemming Ornskov, M.D., Shire CEO designate, said in a statement. Dr. Ornskov will become Shire’s CEO on April 30. “We will build on the work that Premacure has done and will apply Shire’s proven ability in developing protein replacement therapies for rare disorders to bring this much-needed therapy to the market.”

Dr. Ornskov will succeed Angus C. Russell, who in discussing Q4 results with analysts last month mentioned Shire’s ongoing commitment to broadening its product pipeline in rare diseases. The company ended last year undertaking 15 business-development deals and developing three clinical-phase products.

Shire’s acquisition of Premacure comes a month after the rare-disease drug giant reported fourth-quarter results showing declines in sales for its former best-selling drug. Sales of the attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine and dextroamphetamine mixed salts) fell 35% during Q4, to $82 million, and finished all of 2012 with a 19% sales decline, to $429 million.

Shire cited reduced U.S. prescription demand and competition from generics not supplied by Shire, starting with a generic version from Actavis that launched in Q2 2012. Shire can expect even more generic competition for Adderall this year, since FDA on February 12 approved another generic version of the drug, ANDA, to be sold by Teva’s Barr Pharmaceuticals unit.

Product sales during Q4 rose 5% overall compared with the fourth quarter of 2011, to $1.098 billion, and 10% (to $1.016 billion) excluding Adderall XR, as Shire saw double-digit sales gains from other ADHA drugs, notably Vyvanse (up 18% to $257 million in the quarter and more than 28%, to $1 billion, for all of 2012); and Intuniv (up 24% to $81 million in Q4 and 29%, to $288 million for 2012).

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